Hyperfine Enrolls First Patients in Swoop CARE PMR Study

Hyperfine, a company redefining brain imaging, today announced the first patients have been enrolled in its Capturing ARIA Risk Equitably with Portable MR (CARE PMR) observational study which is designed to assess the clinical utility and workflow benefits of its FDA cleared Swoop portable magnetic resonance (MR) brain imaging system obtained at infusion centers and clinics to detect amyloid-related imaging abnormalities (ARIA) in Alzheimer’s patients receiving amyloid-targeting therapy before the fifth, seventh, and 14th infusions.

The Swoop system is a portable, AI-powered, ultra-low-field MR brain imaging system designed to be available when and where physicians need it, potentially allowing for timelier treatment decisions.

Alzheimer’s disease, which affects more than six million people in the United States alone, can now be treated with amyloid-targeting therapy, which reduces the amyloid plaque burden in the brain. However, this treatment does have potential side effects, including ARIA, and patients are required to receive multiple MRI brain scans during the first year of treatment as included in the FDA-approved labeling for the medication.

Hyperfine, in its study, is evaluating whether portable MR brain imaging can reliably identify brain swelling and bleeding — which have been associated with the medication — at the same time as anti-amyloid infusions to lessen the inconvenience for patients, who would otherwise have to go and get a conventional high-field MRI scan, resulting in increased delay and cost.

Washington School of Medicine and Mass General Brigham have both begun scanning patients with the Swoop system.

“The newly approved amyloid-targeting therapy represents a major milestone in the global fight against Alzheimer’s, bringing hope of additional years of independent living to patients,” said Maria Sainz, Hyperfine president and CEO, in the press release announcing the first patients enrolled in the study. “The required MRI scans to image brain abnormalities in patients receiving amyloid-targeting therapy present workflow challenges for patients and providers. Patients can be safely scanned with the Swoop system wherever in a healthcare setting is most convenient, and we believe that it greatly simplifies the workflow and provides significant benefits in care efficiency and cost. We look forward to investigating its potential as a screening tool and exploring how this accessible and affordable portable MRI modality can help address the challenges of access to care and equity challenges intrinsic to new treatments for this devastating global disease.”